Ischemic StrokeCLOTSAFENCT06530927
Microclots and Neutrophil Activation as Potential Indicators for Stroke Risk and Reperfusion Failure
An observational study of Ischemic Stroke, run by University of Zurich at 1 site in Switzerland.
Trial summary
Stroke remains a major health burden worldwide. Many patients are severely disabled and stay in need of care. Mechanical thrombectomy has dramatically improved outcomes for stroke patients with large vessel occlusions, yet 40-50% of patients with successful recanalization remain severely disabled despite successful… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- 3D rotational digital tomography, Atomic Force Microscopy and Micro-Computertomography
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2025to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients without acute stroke (Control Group and chronic Stroke Group) will be recruited at the neurovascular ambulatory of the University Hospital Zurich Patient with acute stroke will be included at the stroke unit of the University Hospital Zurich.
Who may be able to join
- Patients without acute stroke CS or CSG
- No previous stroke or previous stroke ≥ 1 year ago
- Signed informed consent
- Patients with acute stroke (AS-noTx, AS-IVT, AS-MT):
- Patients admitted with high suspicion of acute ischemic stroke
- Time of onset of stroke symptoms ≤ 12 hours
- Consent according to the regulations of research in an emergency situation
- Ischemic stroke later confirmed
Who cannot join
- All groups:
- Pregnancy
- Age under 18 years
- Acute Stroke no Therapy
- Acute treatment with IVT or with MT
- Acute Stroke IVT-Group • Acute treatment with MT or without IVT
- Acute Stroke MT-Group
- Acute treatment without MT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Susanne Wegener, Prof., 0041442551078, susanne.wegener@usz.ch
Lukas Otto, Dr., 0041432351301, lukasbastian.otto@usz.ch
About this study
Official title: Micro-clots and Neutrophil Activation as Potential Indicators for Stroke Risk and Reperfusion Failure The CLOTSAFE - Study (Micro-CLOTs, Stroke Risk, Activated Neutrophils, Reperfusion FailurE)
Stroke remains a major health burden worldwide. Many patients are severely disabled and stay in need of care. Mechanical thrombectomy has dramatically improved outcomes for stroke patients with large vessel occlusions, yet 40-50% of patients with successful recanalization remain severely disabled despite successful recanalization, a scenario called "futile recanalization". One of the causes for this lack of treatment effect is capillary obstruction, or "no reflow", potentially resulting from activated neutrophils and micrometer-sized blood clots. To address this issue, we employ digital holotomographic and atomic force microscopy to investigate the structural and chemical characteristics of blood and clot material in stroke patients and individuals at high risk of developing a stroke. Our study elucidates the association of activated neutrophils and microclots with stroke risk, and may be associated with clinical outcome, stroke ethology and reperfusion failure in patients with stroke. Leveraging label-free microscopy tools, could potentially lead to the discovery of new biomarkers for individualized stroke treatment and prevention, ultimately offering rapid identification of at risk patients and improving clinical outcomes
Read the detailed description
Background:
Stroke remains a major health burden worldwide. Many patients are severely disabled and stay in need of care. Since introducing mechanical thrombectomy as a therapeutic option, clinical outcome has drastically improved over the last few years. However, despite successful macrovascular reperfusion (recanalization), patients with stroke still have a significant risk (about 40-50%) of remaining severely disabled, a scenario called "futile recanalization". One of the causes for this lack of treatment effect is capillary obstruction, or "no reflow", potentially resulting from activated neutrophils and micrometer-sized blood clots. Previous work in rodent stroke models demonstrated that removal of these capillary stalls indeed improves reperfusion and recovery after stroke. However, there is a lack of knowledge regarding the role of neutrophils or microclots in patients with stroke, and their potential to indicate reperfusion failure.
Aim:
The goal of our study is to search for activated neutrophils and microclots in peripheral blood samples from patients with stroke. We anticipate that neutrophil and microclot characteristics such as size, shape, or surface structure may indicate stroke risk, and may be associated with clinical outcome, stroke ethology and reperfusion failure in patients with stroke. Our goal is to improve the prediction of stroke risk and treatment success.
Methodology:
We plan to prospectively include 500 patients with acute and chronic stroke, as well as a control group. We have teamed up with biophysicists from the Swiss Federal Laboratories for Materials Science (EMPA) using the novel microscopic tools 3D rotational digital tomography (DHTM) to achieve an unprecedented resolution of less than 10 μm for detection of altered neutrophil phenotypes and microclots in peripheral blood samples. Furthermore, in patients undergoing mechanical thrombectomy, retrieved clots will be analyzed with high-density micro-computertomography (micro-CT). Quantity, mechanical and structural properties of microclots and neutrophils will be correlated with risk of reperfusion failure, stroke recurrence and clinical recovery. Analyses of clots from patients with large vessel occlusion will be used to derive risk of reperfusion failure along with most likely source of the clot, and thus, most likely stroke etiology.
Potential Significance:
Current diagnostic tools are insufficient to predict response to treatment, clot source or stroke recurrence risk. Our project has the potential to discover new, clinically applicable biomarkers identifying patients at risk within a few hours, enabling individualized stroke treatment and prevention.
- Conditions
- Ischemic Stroke
- Being tested
- 3D rotational digital tomography, Atomic Force Microscopy, Micro-Computertomography
- Keywords
- microclots, activated neutrophils, reperfusion failure, 3D rotational digital tomography
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D rotational digital tomographyDiagnostic test
DHTM is label-free and records the phase shift of low-energy light passing through the specimen on a transparent surface with minimal perturbation. DHTM measures the refractive index (RI) and computes the refractive index gradient (RIG), unveiling optical heterogeneity in cells. We will analyze blood samples for the detection of altered neutrophil phenotypes and microclots.
Atomic Force MicroscopyDiagnostic test
The atomic force microscope (AFM) is widely used in materials science and has found many applications in biological sciences but has been limited in use in vision science. The AFM can be used to image the topography of soft biological materials in their native environments. We will analyze blood samples for the detection of altered neutrophil phenotypes and microclots
Micro-ComputertomographyDiagnostic test
Micro-CT is a 3D imaging technique utilizing X-rays to see inside an object, slice by slice. Micro-CT, also called microtomography or micro computed tomography, is similar to hospital CT or "CAT" scan imaging but on a small scale with greatly increased resolution. Samples can be imaged with pixel sizes as small as 100 nanometers and objects can be scanned as large as 200 millimeters in diameter. We will use micro-CT to analyze blood clots from patients with large vessel occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Patients without previous documented stroke Receives: Diagnostic Test: 3D rotational digital tomography; Diagnostic Test: Atomic Force Microscopy | |
| Chronic Stroke Group | Patients with previous stroke ≥1year ago Receives: Diagnostic Test: 3D rotational digital tomography; Diagnostic Test: Atomic Force Microscopy | |
| Acute Stroke No Therapy Group | Patients with acute stroke, but without intravenous thrombolysis or mechanical thrombectomy Receives: Diagnostic Test: 3D rotational digital tomography; Diagnostic Test: Atomic Force Microscopy | |
| Acute Stroke IVT only Group | Patients with acute stroke and intravenous thrombolysis Receives: Diagnostic Test: 3D rotational digital tomography; Diagnostic Test: Atomic Force Microscopy | |
| Acute Stroke MT-Group | Patients with acute stroke and mechanical thrombectomy Receives: Diagnostic Test: 3D rotational digital tomography; Diagnostic Test: Atomic Force Microscopy; Diagnostic Test: Micro-Computertomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification and characterization of microclots
3D rotational digital tomography and atomic force microscopy
imaging outcome measurements:
- size: length (µm), width (µm)
- dry mass (g/dl)
- praevalence (count in numbers)
- composition (platelet aggregate vs. fibrin-rich microclots vs. microclot composite)
Measured: First Visit/Admission and patients with acute stroke after 24 hours, 3 months and 1 year
Quantification and characterization of neutrophils
3D rotational digital tomography and atomic force microscopy
image morphological outcome measurements:
- size: diameter (µm), surface area (µm2), volume (fl), thickness (µm), sphericity
- dry mass (g/dl)
- praevalence (count in numbers)
- activation state (activated vs. not activated vs. dead)
Measured: First Visit/Admission and patients with acute stroke after 24 hours, 3 months and 1 year
Evaluation of reperfusion failure in patients with large vessel occlusion and mechanical thrombectomy
Defined by successfull macrovascular reperfusion (TICI >=2c) and insufficient microvascular reperfusion with the outcome measurment (yes/no)
Successfull macrovasular reperfusion is defined according to the mTICI score 2c or 3.
Microvascular reperfusion success will be evaluated with thresholds were used to discriminate between microvascular hypoperfusion and reperfusion, calculated from perfusion images obtained on computed tomography (CTP) or magnetic resonance perfusion imaging (MRP).
Measured: <24 hours in patients with mechanical thrombectomy
Secondary outcomes (5)
Change in National Institute of Health Score Scale (NIHSS)
will be assessed using National Institutes of Health Stroke Scale (NIHSS)
NIHSS
13 assessed functional domains Range 0-42, higher score indicates severe impairment
Measured: First Visit/Admission and patients with acute stroke after 24 hours, 3 months and 1 year
Degree of disability or dependence assessed by the modified ranking scale (mRS)
will be assessed using modified Rankin Scale (mRS)
mRS
Range: (0-6) 0 = no symptoms, 6 = death, higher score indicates severe impairment
Measured: First Visit/Admission and patients with acute stroke after 24 hours, 3 months and 1 year
Assessment Quality of Life using European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
EQ-5D-5L
Evaluation of 5 different aspects of health with likert scale (1-5)
MOBILITY SELF-CARE USUAL ACTIVITIES PAIN / DISCOMFORT ANXIETY / DEPRESSION Each domain is scored individually, higher values indicate higher impairment of quality of life
Measured: 365 days
Incidence of new cardiovascular disease
Stroke, heart attack, brain bleeding
Measured: 365 days
All-cause mortality
Mortality
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Feb 2025
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Empa, Swiss Federal Laboratories for Materials Science and Technology
- Responsible party
- Principal investigator, Susanne Wegener, University of Zurich
- Investigators
- Susanne Wegener, Prof., Principal investigator, University Hospital Zurich, department Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530927
- Sponsor's protocol ID
- 2024-01353
- Acronym
- CLOTSAFE
- Status last verified
- Mar 2025
- First submitted
- 28 Jul 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be decided upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-clots and Neutrophil Activation as Potential Indicators for Stroke Risk and Reperfusion Failure The CLOTSAFE - Study (Micro-CLOTs, Stroke Risk, Activated Neutrophils, Reperfusion FailurE)
- ClinicalTrials.gov ID
- NCT06530927
- Acronym / sponsor ID
- CLOTSAFE / 2024-01353
- Conditions
- Ischemic Stroke
- Keywords
- microclots, activated neutrophils, reperfusion failure, 3D rotational digital tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Empa, Swiss Federal Laboratories for Materials Science and Technology
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke remains a major health burden worldwide. Many patients are severely disabled and stay in need of care. Mechanical thrombectomy has dramatically improved outcomes for stroke patients with large vessel occlusions, yet 40-50% of patients with successful recanalization remain severely disabled despite successful recanalization, a scenario called "futile recanalization". One of the causes for this lack of treatment effect is capillary obstruction, or "no reflow", potentially resulting from activated neutrophils and micrometer-sized blood clots. To address this issue, we employ digital holotomographic and atomic force microscopy to investigate the structural and chemical characteristics of blood and clot material in stroke patients and individuals at high risk of developing a stroke. Our study elucidates the association of activated neutrophils and microclots with stroke risk, and may be associated with clinical outcome, stroke ethology and reperfusion failure in patients with stroke. Leveraging label-free microscopy tools, could potentially lead to the discovery of new biomarkers for individualized stroke treatment and prevention, ultimately offering rapid identification of at risk patients and improving clinical outcomes
Detailed description
Background:
Stroke remains a major health burden worldwide. Many patients are severely disabled and stay in need of care. Since introducing mechanical thrombectomy as a therapeutic option, clinical outcome has drastically improved over the last few years. However, despite successful macrovascular reperfusion (recanalization), patients with stroke still have a significant risk (about 40-50%) of remaining severely disabled, a scenario called "futile recanalization". One of the causes for this lack of treatment effect is capillary obstruction, or "no reflow", potentially resulting from activated neutrophils and micrometer-sized blood clots. Previous work in rodent stroke models demonstrated that removal of these capillary stalls indeed improves reperfusion and recovery after stroke. However, there is a lack of knowledge regarding the role of neutrophils or microclots in patients with stroke, and their potential to indicate reperfusion failure.
Aim:
The goal of our study is to search for activated neutrophils and microclots in peripheral blood samples from patients with stroke. We anticipate that neutrophil and microclot characteristics such as size, shape, or surface structure may indicate stroke risk, and may be associated with clinical outcome, stroke ethology and reperfusion failure in patients with stroke. Our goal is to improve the prediction of stroke risk and treatment success.
Methodology:
We plan to prospectively include 500 patients with acute and chronic stroke, as well as a control group. We have teamed up with biophysicists from the Swiss Federal Laboratories for Materials Science (EMPA) using the novel microscopic tools 3D rotational digital tomography (DHTM) to achieve an unprecedented resolution of less than 10 μm for detection of altered neutrophil phenotypes and microclots in peripheral blood samples. Furthermore, in patients undergoing mechanical thrombectomy, retrieved clots will be analyzed with high-density micro-computertomography (micro-CT). Quantity, mechanical and structural properties of microclots and neutrophils will be correlated with risk of reperfusion failure, stroke recurrence and clinical recovery. Analyses of clots from patients with large vessel occlusion will be used to derive risk of reperfusion failure along with most likely source of the clot, and thus, most likely stroke etiology.
Potential Significance:
Current diagnostic tools are insufficient to predict response to treatment, clot source or stroke recurrence risk. Our project has the potential to discover new, clinically applicable biomarkers identifying patients at risk within a few hours, enabling individualized stroke treatment and prevention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Diagnostic Test: 3D rotational digital tomography, Diagnostic Test: Atomic Force MicroscopyPatients without previous documented stroke |
| Chronic Stroke Group | – | Diagnostic Test: 3D rotational digital tomography, Diagnostic Test: Atomic Force MicroscopyPatients with previous stroke ≥1year ago |
| Acute Stroke No Therapy Group | – | Diagnostic Test: 3D rotational digital tomography, Diagnostic Test: Atomic Force MicroscopyPatients with acute stroke, but without intravenous thrombolysis or mechanical thrombectomy |
| Acute Stroke IVT only Group | – | Diagnostic Test: 3D rotational digital tomography, Diagnostic Test: Atomic Force MicroscopyPatients with acute stroke and intravenous thrombolysis |
| Acute Stroke MT-Group | – | Diagnostic Test: 3D rotational digital tomography, Diagnostic Test: Atomic Force Microscopy, Diagnostic Test: Micro-ComputertomographyPatients with acute stroke and mechanical thrombectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients without acute stroke (Control Group and chronic Stroke Group) will be recruited at the neurovascular ambulatory of the University Hospital Zurich Patient with acute stroke will be included at the stroke unit of the University Hospital Zurich.
Key inclusion criteria (8 listed)
- Patients without acute stroke CS or CSG
- No previous stroke or previous stroke ≥ 1 year ago
- Signed informed consent
- Patients admitted with high suspicion of acute ischemic stroke
- Time of onset of stroke symptoms ≤ 12 hours
Key exclusion criteria (8 listed)
- Pregnancy
- Age under 18 years
- Acute Stroke no Therapy
- Acute treatment with IVT or with MT
- Acute Stroke IVT-Group • Acute treatment with MT or without IVT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D rotational digital tomographyDHTM is label-free and records the phase shift of low-energy light passing through the specimen on a transparent surface with minimal perturbation. DHTM measures the refractive index (RI) and computes the refractive index gradient (RIG), unveiling optical heterogeneity in cells. We will analyze blood samples for the detection of altered neutrophil phenotypes and microclots. | Diagnostic test | Acute Stroke IVT only Group, Acute Stroke MT-Group, Acute Stroke No Therapy Group, Chronic Stroke Group, Control Group |
| Atomic Force MicroscopyThe atomic force microscope (AFM) is widely used in materials science and has found many applications in biological sciences but has been limited in use in vision science. The AFM can be used to image the topography of soft biological materials in their native environments. We will analyze blood samples for the detection of altered neutrophil phenotypes and microclots | Diagnostic test | Acute Stroke IVT only Group, Acute Stroke MT-Group, Acute Stroke No Therapy Group, Chronic Stroke Group, Control Group |
| Micro-ComputertomographyMicro-CT is a 3D imaging technique utilizing X-rays to see inside an object, slice by slice. Micro-CT, also called microtomography or micro computed tomography, is similar to hospital CT or "CAT" scan imaging but on a small scale with greatly increased resolution. Samples can be imaged with pixel sizes as small as 100 nanometers and objects can be scanned as large as 200 millimeters in diameter. We will use micro-CT to analyze blood clots from patients with large vessel occlusion. | Diagnostic test | Acute Stroke MT-Group |
Primary outcome
Quantification and characterization of microclots
Time frame: First Visit/Admission and patients with acute stroke after 24 hours, 3 months and 1 year
3D rotational digital tomography and atomic force microscopy imaging outcome measurements: * size: length (µm), width (µm) * dry mass (g/dl) * praevalence (count in numbers) * composition (platelet aggregate vs. fibrin-rich microclots vs. microclot composite)
Quantification and characterization of neutrophils
Time frame: First Visit/Admission and patients with acute stroke after 24 hours, 3 months and 1 year
3D rotational digital tomography and atomic force microscopy image morphological outcome measurements: * size: diameter (µm), surface area (µm2), volume (fl), thickness (µm), sphericity * dry mass (g/dl) * praevalence (count in numbers) * activation state (activated vs. not activated vs. dead)
Evaluation of reperfusion failure in patients with large vessel occlusion and mechanical thrombectomy
Time frame: <24 hours in patients with mechanical thrombectomy
Defined by successfull macrovascular reperfusion (TICI >=2c) and insufficient microvascular reperfusion with the outcome measurment (yes/no) Successfull macrovasular reperfusion is defined according to the mTICI score 2c or 3. Microvascular reperfusion success will be evaluated with thresholds were used to discriminate between microvascular hypoperfusion and reperfusion, calculated from perfusion images obtained on computed tomography (CTP) or magnetic resonance perfusion imaging (MRP).
5 secondary outcomes
Change in National Institute of Health Score Scale (NIHSS)
Time frame: First Visit/Admission and patients with acute stroke after 24 hours, 3 months and 1 year
Degree of disability or dependence assessed by the modified ranking scale (mRS)
Time frame: First Visit/Admission and patients with acute stroke after 24 hours, 3 months and 1 year
Assessment Quality of Life using European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Time frame: 365 days
Incidence of new cardiovascular disease
Time frame: 365 days
All-cause mortality
Time frame: 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: Undecided. Will be decided upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanne Wegener, Prof. principal investigator
University Hospital Zurich, department Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukas Otto, Dr. med. (+41 43 253 13 01, lukasbastian.otto@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification and characterization of microclots (time frame: First Visit/Admission and patients with acute stroke after 24 hours, 3 months and 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.